The subject matter relates to a system for measurement of deep tissue temperature (DTT) as an indication of the core body temperature of humans or animals. More particularly, the subject matter relates to constructions and operations of a zero-heat-flux DTT measurement system with a cable interface for connection to a disposable DTT probe.
Deep tissue temperature is a proxy measure for core temperature, which is the mass-weighted mean temperature of the body contents. It is desirable to maintain core body temperature in a normothermic range in many clinical situations. For example, during the perioperative cycle maintenance of normothermia has been shown to reduce the incidence of many adverse consequences of anesthesia and surgery, including surgical site infections and bleeding; accordingly, it is beneficial to monitor a patient's body core temperature before, during, and after surgery. Of course noninvasive measurement is highly desirable, for the safety and the comfort of a patient, and for the convenience of the clinician. Thus, it is most advantageous to obtain a noninvasive DTT measurement by way of a device placed on the skin.
Noninvasive measurement of DTT by means of a zero-heat-flux device was described by Fox and Solman in 1971 (Fox R H, Solman A J. A new technique for monitoring the deep body temperature in man from the intact skin surface. J. Physiol. Jan 1971:212(2): pp 8-10). Because the measurement depends on the absence of heat flux through the skin area where measurement takes place, the technique is referred to as a “zero-heat-flux” (ZHF) temperature measurement. The Fox/Solman system, illustrated in FIG. 1, estimates core body temperature using a ZHF temperature measurement device 10 including a pair of thermistors 20 separated by layer 22 of thermal insulation. A difference in the temperatures sensed by the thermistors 20 controls operation of a heater 24 of essentially planar construction that stops or blocks heat flow through a skin surface area contacted by the lower surface 26 of the device 10. A comparator 29 measures the difference in the sensed temperatures and provides the difference measurement to a controller 30. The heater 24 is operated for so long as the difference is non-zero. When the difference between the sensed temperatures reaches zero, the zero heat flux condition is satisfied, and the heater 24 is operated as needed to maintain the condition. The thermistor 20 at the lower surface 26 senses a temperature near, if not equal to, that of the skin surface area and its output is amplified at 36 and provided at 38 as the system output. Togawa improved the Fox/Solman measurement technique with a DTT measurement device structure that accounted for multidimensional heat flow in tissue. (Togawa T. Non-Invasive Deep Body Temperature Measurement. In: Rolfe P (ed) Non-Invasive Physiological Measurements. Vol. 1. 1979. Academic Press, London, pp. 261-277). The Togawa device encloses a Fox and Solman-type ZHF design in a thick aluminum housing with a cylindrical annulus construction that reduces or eliminates radial heat flow from the center to the periphery of the device.
The Fox/Solman and Togawa devices utilize heat flux normal to the body to control the operation of a heater that blocks heat flow from the skin through a thermal resistance in order to achieve a desired zero heat flux condition. This results in a construction that stacks the heater, thermal resistance, and thermal sensors of a ZHF temperature measurement device, which can result in a substantial vertical profile. The thermal mass added by Togawa's cover improves the stability of the Fox/Solman design and makes the measurement of deep tissue temperature more accurate. In this regard, since the goal is to achieve zero heat flux through the device, the more thermal resistance the better. However, the additional thermal resistance adds mass and size, and also increases the time required to reach a stable temperature.
The size, mass, and cost of the Fox/Solman and Togawa devices do not promote disposability. Consequently, they must be sanitized after use, which exposes them to wear and tear and undetectable damage. The devices must also be stored for reuse. As a result, use of these devices raises the costs associated with zero-heat-flux DTT measurement and can pose a significant risk of cross contamination between patients. It is thus desirable to reduce the size and mass of a zero-heat-flux DTT measurement device, without compromising its performance, in order to promote disposability.
Inexpensive, disposable, zero-heat-flux DTT measurement devices are described and illustrated in the related US patent applications (“the related applications”). A measurement device constructed according to the related applications is attached to the skin of a human or animal subject to sense the temperature of tissue deep under the skin. The measurement device is constituted of a flexible substrate and an electrical circuit disposed on a surface of the flexible substrate. The electrical circuit includes an essentially planar heater which is defined by an electrically conductive copper trace and which surrounds an unheated zone of the surface, a first thermal sensor disposed in the zone, a second thermal sensor disposed outside of the heater trace, a plurality of contact pads disposed outside of the heater trace, and a plurality of conductive traces that connect the first and second thermal sensors and the heater trace with the plurality of contact pads. Sections of the flexible substrate are folded together to place the first and second thermal sensors in proximity to each other. A layer of insulation disposed between the sections separates the first and second thermal sensors. The measurement device is oriented for operation so as to position the heater and the first thermal sensor on one side of the layer of insulation and the second thermal sensor on the other and in close proximity to an area of skin where a measurement is to be taken. The layout of the electrical circuit on a surface of the flexible substrate provides a low-profile, zero-heat-flux DTT measurement device that is essentially planar, even when the sections are folded together. Such devices are referred to as “sensors” or “probes”. In the following specification such a device will be referred to as a “probe” in order to avoid ambiguity with respect to the term “thermal sensor”, which is used in the specification to denote a device having an electrical property that changes in response to a change in temperature.
Given the advances in construction and performance of lightweight, disposable probes as is evidenced in the related applications, it is now desirable to establish system mechanizations and procedures that quickly produce accurate and reliable temperature measurements in response to sensed data produced by such probes. In particular, there is a need for a zero-heat-flux deep tissue temperature (DTT) measurement system that measures internal body temperature by way of a lightweight, disposable measurement probe that includes a heater and thermal sensors disposed in a zero-heat-flux construction.
Further, such a measurement system can have a construction customized for stand-alone operation. That is to say, one that does not include a standard signal output that can be accepted as an input by multi-function patient monitors. However, it is desirable that such an output signal interface conforming to a standard device or a standard input signal configuration defined for multi-function patient monitors would increase the versatility and usefulness of such a zero-heat-flux DTT measurement system.